Introduction

Trays of medical devices await decontamination after use. With some surgeries now requiring more than 15 trays, hospitals are struggling for space.

University of Michigan Health System

An outbreak of infections and deaths apparently linked to poorly cleaned medical scopes at a Los Angeles hospital is bringing renewed attention to the broader problem of dirty surgical instruments — the subject of a major Center investigation.

In recent days, an antibiotic-resistant “superbug” known as CRE killed two people and infected five others at UCLA’s Ronald Reagan Medical Center; an estimated 179 more patients may have been exposed from October to January after undergoing a procedure called an endoscopic retrograde cholangiopancreatography. Authorities suspect the deadly germs were transmitted by inadequately sterilized medical scopes used in the procedure, known as duodenoscopes, which are difficult to clean because of their complex design.

But a 2012 investigation by the Center for Public Integrity revealed that the problem of dirty instruments is national in scope, and defies easy solutions. A companion piece was done by NBC’s TODAY show. The Center series, “Filthy surgical instruments: The hidden threat in America’s operation rooms,” detailed how contaminated medical instruments have been showing up in hospitals and outpatient surgery centers with alarming regularity. In 2009, the Department of Veterans Affairs Affairs admitted that 10,737 veterans in Florida, Tennessee and Georgia were given endoscopies or colonoscopies since 2002 with endoscopes that may have been inadequately cleaned. Investigation of a 2008 hepatitis C outbreak that sickened at least six people in Las Vegas revealed that an outpatient surgery center was improperly cleaning endoscopes and reusing biopsy forceps designed for a single use.

February 22, 2012

At a little-noticed 2011 Food and Drug Administration workshop on the problem, some critics put the blame on poor or overly-complex design of instruments. Decades ago, medical instruments were almost exclusively made of steel and glass, and many resembled the tools used by butchers or auto mechanics. Cleaning those tools was easy, and sterilization required little more than a heavy shot of steam.

The growth of minimally invasive surgeries in the 1990s, however, brought flexible endoscopes that are passed through tiny incisions to see inside patients. Instruments became smaller, more specialized and complicated, with moving parts, tiny holes and long, narrow, hard-to-clean channels running the length of the implements.

August 29, 2016

May 9, 2016

At the FDA workshop, experts pointed to the proliferation of complex instruments, but also cited inadequate testing by manufacturers and the struggle faced by poorly-paid hospital employees who clean and sterilize devices in between procedures, often under pressure from nurses and surgeons who need the devices quickly for the next procedure.

In a letter sent today, a California lawmaker is calling on Congress to investigate what the FDA and device makers are doing to prevent more infections, according to the Los Angeles Times. In his letter, U.S. Rep. Ted Lieu told the House Committee on Oversight and Government Reform that disease outbreaks linked to dirty instruments “have national security ramifications.” Lieu told the Times that a recent FDA safety alert issued in response to the UCLA problems provides no assurances that more outbreaks could be prevented.

“While federal agencies such as the Centers for Disease Control and Prevention are combating superbugs,” Lieu said, “the current recommended sterilization procedures would continue to result in superbug outbreaks and deaths.”